FDA-Drug2024-07-03Class II
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Sold states
Nationwide in the U.S.
Affected count
21,655 (30 count bottle), 34,149 (90 count bottle)
Manufactured in
5187 Camino Ruiz, Camarillo, CA, United States
Products
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0568-2024More Golden State Medical Supply Inc. recalls
- FDA-Drug2026-06-17Golden State Medical Supply niacin extended-release tablets recalled for failed dissolution
- FDA-Drug2026-05-27Golden State Medical Supply Primidone Tablets recalled for Acemetacin contamination
- FDA-Drug2026-05-27Golden State Medical Supply Primidone tablets recalled for Acemetacin contamination
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